Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery

NCT01509118 | Unknown

• 1 other identifier: 15635
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

Brief Summary

Arterial and venous thromboembolism represents one of the most common preventable health problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis, the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly 4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.

Conditions

Open Fracture of Hip

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rivaroxaban safety profile will be observed in 500 patients

You may qualify if:

• At least 50 years old in men or post-menopause in women
• Patients, who are undergoing standard surgery for fracture of the upper third of the femur, including femoral head, neck, trochanteric and sub-trochanteric fracture and the surgery is planned within 7 days after admission
• Patients, who are eligible for thromboprophylaxis. Such patients will be enrolled only after physician's decision to prescribe rivaroxaban for thromboprophylaxis has been made. The decision is totally based on standard of medical practice.
• Patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.

You may not qualify if:

• Trauma affecting more than 1 organ system
• Pathological fracture secondary to malignant disease
• Clinically significant bleeding excluding drainage
• Documented congenital or acquired bleeding disorder
• Patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to FDA-approved product label
• Patient on oral anticoagulation therapy in the past 7 days
• Pregnancy or breastfeeding
• Patients who are simultaneously participating in a different study

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Chulalongkorn University: collaborator
• Chiang Mai University: collaborator
• Thammasat University: collaborator
• Police General Hospital: collaborator
• Saint Louis Hospital,bangkok,Thailand: collaborator
• Bhumibol Adulyadej Hospital: collaborator

Study Sites (7)

Orthopedic/Board of Orthopedic Surgery, Saint Louis Hospital

Bangkok, Bangkok, 10120, Thailand

RECRUITING

Department of Orthopedic Surgery, Bhumibol Adulyadej Hospital

Bangkok, Bangkok, 10220, Thailand

NOT YET RECRUITING

Department of Orthopaedics, Chulalongkorn Hospital

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

Department of Orthopedic Surgery, Police General Hospital

Pathumwan, Bangkok, 10400, Thailand

RECRUITING

Department of Orthopaedic surgery Pharmongkutklao Hospital

Rajathevee, Bangkok, 10400, Thailand

RECRUITING

Department of Orthopaedics, Thammasat University

Klong Luang, Changwat Pathum Thani, 12121, Thailand

RECRUITING

Department of Orthopaedic Surgery,Chiang Mai University

Muang, Chiang Mai, 50200, Thailand

RECRUITING

Study Officials

• Thanainit Chotanaphut, M.D.

  Department of Orthopaedic Surgery Pharmongkutklao Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colonel

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: January 12, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

TH (7)